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PROFESSIONAL ACTIVITIES: BioTox has managed and prepared the following individual projects: - >200 Toxicological Profiles
- >10
Proposition 65 Assessments
- >20 Occupational Exposure Limits (OELs)
- >25 Risk Assessments
- >10 No Significant Risk Levels (NSRLs)
- >18 GRAS self determinations
- numerous SDSs
- numerous
REACH evaluations
- numerous LHAMA evaluations
In addition, Dr. Kapp has acted as Study Director on >1500 studies in private industry for
numerous clients and has testified or been deposed in 25 legal cases. He has also been involved with many Government
and Industrial Panels and Committees and many other projects too numerous to be included in this summary. PROFESSIONAL EXPERIENCE:
1989 - present
President/Principal Scientist
BioTox
- Toxicology consultation service
in designing protocols, placing, implementing and monitoring programs. The company's principal has numerous direct interactions
with trade organizations, animal welfare groups, governmental agencies, manufacturers, academia, and the legal community.
- Special hands on experience in laboratory facility design, oversight, organization and management.
- Scientific
specialties include evaluation, placement and monitoring of the following:
- Chronic/Carcinogenicity/Subchronic Studies
- Genetic Toxicology
- Reproduction/Developmental Toxicology
Other services available: - GRAS Panels submissions to FDA
- Various Toxicological Aspects of the Petrochemical Industry
- Expert Witness
Testimony/Deposition
- Facility Review
- Laboratory Organization
and Design Compliance with Good Laboratory Practice
- Industrial Hygiene Evaluation
- Protocol Evaluation/Preclinical and Clinical Study Monitoring
- BioTox
has managed >$20MM in worldwide laboratory testing in the US, Europe, China and Brazil.
- MSDS creation and maintenance - Global Compliance - EU, WHMIS, Japan, US.
- Regulatory
Compliance Including:
- FDA (IND, FCN, 510K, GRAS)
- EPA (FIFRA,
PMN)
- OECD (REACH)
- OSHA (Labeling and Testing)
- CPSC (Labeling and Testing)
- Industry Task Force Management
and Representation
- Environmental Affairs
- SIDS Dossiers and
SIAR Preparation
- General Toxicology Counsel
*********************************************************** 1979 – 1989 Director, Toxicology Laboratory Exxon
Biomedical Sciences, Inc. Mettlers Road, CN 2350 East Millstone, NJ 08875-2350 Staff of approximately
140 including 15 Ph.D.’s and 25 contract employees: - 10 Department Managers
- 100,000 square foot facility
- 95% of Exxon Corporation toxicology testing performed at this site
- Initiated, marketed
and maintained a $3 million plus third party testing program with pharmaceutical, agricultural, and food products firms.
- Interaction with new products/formulations for review by EPA, FDA, CPSC, and/or the DOT and for international
agencies such as the European Economic Community (EEC).
- Close working relations and understanding
of Quality Assurance and the GLP regulations.
- Acted as primary interface between Exxon scientific
staff and Exxon laboratory staff and was the primary interaction with all third party clients.
- Departments included all phases of mammalian and environmental toxicology including acute, subchronic, chronic, reproduction,
and developmental projects.
- Direct stewardship responsibilities of manpower, fiscal budgets,
project assignments, staff training, and future direction of the laboratory.
*********************************************************** 1978 – 1979 Senior Staff Toxicologist Toxicology Department Hazleton Laboratories America,
Inc. (now Covance) Vienna, Virginia - Staff
of 25
- 2 professional managers
- Expanded responsibilities
to include long term carcinogenicity and mutagenicity studies.
- Personally directed about
175 scientific projects (scientific and fiscal responsibility).
- Set up the company's first
Genetic Toxicology Department.
*********************************************************** 1973
– 1977 Staff Toxicologist Toxicology
Department Hazleton Laboratories America, Inc. (now Covance) Vienna, Virginia - Staff of 15
- Responsible for all Acute, Reproduction and Genetic studies - scheduling/budgeting.
- Personally directed over 150 scientific projects (scientific and fiscal
responsibility).
*********************************************************** 1970 – 1972 Corpsman, US
Navy Head, Cytogenetics Division Anatomical Pathology National
Naval Medical Center Bethesda, Maryland - 3 person staff
- Responsible for the set up, financial and technical control of the US Navy's only worldwide cytogenetics
laboratory.
- Provided assistance with medical interpretation
of genetic tests and reports of the genetics center laboratory.
- Coordinated research activities between the National Institute of Medical Research (NMRI) and the National Institutes
of Health (NIH).
*********************************************************** 1968 - 1970 Corpsman US Navy
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